FDA 510(k) clearances — page 65
clearances on record, most recent first.
Clearances — page 65
6,401–6,500 of 176,479- K242595 — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
- K242702 — VioSeal
- K242734 — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
- K240450 — Citrepore
- K240831 — MultiCut Solo
- K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K242039 — Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
- K242261 — Accelx Implant System
- K242412 — Agility Symmetric Total Knee System
- K242719 — ELEXIR 2.0 (ALLIVE3)
- K242803 — Compound W Skin Tag Remover
- K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more
- K231287 — POTENZA
- K240624 — InfuLife
- K241312 — TeraRecon Cardiac.Chambers.MR (1.0.0)
- K241484 — Atlas Humeral Nail System
- K241849 — MEDRAD Centargo CT Injection System +4 more
- K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
- K242340 — DESS Dental Smart Solutions
- K242345 — Delphi Stimulator
- K242664 — gentleheel® Adult Incision Device
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K243015 — Skyway Anterior Cervical Plate System
- K243106 — CarboClear® Hybrid Pedicle Screw System
- DEN230083 — Valeda Light Delivery System
- K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
- K240512 — Tixel i (TXLI0001)
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K242195 — Gemini Cervical Fusion Cage System
- K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
- K242709 — JLK-PWI
- K243061 — SonoStik Guide Wire Introducer
- K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more
- K240388 — Osteotomy Truss System (OTS)
- K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set
- K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
- K241068 — uDR 780i
- K241646 — ORTIV (ORTIV-BL, ORTIV-WH)
- K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit
- K241999 — Prophecy Surgical Planning System
- K242076 — VersaCross RF Wire
- K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- K242311 — EXPERT - Flexible Joint Fixation System
- K242320 — BD Vacutainer® One Use Holder
- K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- K242452 — Monkey Bars Pin to Bar External Fixation System
- K242591 — XERO-alpha
- K242620 — Breo Laser Hair Growth Comb (Scalp 3L)
- K242665 — DePuy ATTUNE Total Knee System
- K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
- K243091 — Over-tube (TR-1108A)
- K243217 — Legend X Desktop System
- K243381 — Total Wrist Arthroplasty System (TWA)
- K240375 — V80 Anesthetic Vaporizer (V80)
- K240383 — Highness Implant System
- K240455 — BD Vacutainer® Citrate Blood Collection Tubes
- K240653 — SmartCardia 7L Platform (MCT)
- K241223 — eRAD PACS
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K242399 — Bonebridge Osteosynthesis Plating System
- K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
- K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
- DEN230082 — Stone Clear (SC-LP9-01)
- K240177 — Zio AT® device (A100A1001)
- K240333 — Wearable Digital Thermometer (T31)
- K240334 — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
- K240560 — ZENEX Implant System_Long
- K240670 — DRI Ecstasy Plus Assay
- K240847 — MedicCO2LON (MedicCO2LON)
- K241108 — RemedyLogic AI MRI Lumbar Spine Reader
- K241533 — NeurAxis IB-Stim (01-1020)
- K241902 — Edison System
- K242271 — Caduceus S
- K242627 — Safety Lancet
- K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
- K243186 — Symbia Pro.specta Q3 (11364751) +3 more
- K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- K241077 — DeGen Medical Patient Specific Implant (PSI) System
- K241189 — Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)
- K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
- K241612 — Video Bronchoscope System +2 more
- K241965 — Catheter Surface Flap Applicator Set (GM11011830)
- K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel
- K243080 — Riptide Aspiration System
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K243126 — TRACHEOBRONXANE DUMON®
- K243157 — AtriCure cryoICE BOX (ACM)
- K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor
- K243247 — Persona the Personalized Knee System
- K240303 — MetaLite DX Digital Pathology Software
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more
- K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- K241992 — Catalyft LS Expandable Interbody System
- K242350 — Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
- K242622 — Sterile Lancets for Single Use
- K243137 — Curiteva Porous PEEK Laminoplasty System
- DEN230084 — Dexter L6 System
- K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more
- K240092 — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
- K240223 — FMT Disposable and Autoclavable Temperature Probes
Data sourced from openFDA. This site is unofficial and independent of the FDA.